Recall Z-0114-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0114-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-13

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-08-13, terminated 2016-08-18. It names one FDA 510(k) clearance: K110789. Product: Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. Reason: When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-13
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K110789 — SYNTHES STERNAL ZIPFIX SYSTEMSynthes (Usa)·cleared 2011-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

Reason for recall

When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.

Data sourced from openFDA. This site is unofficial and independent of the FDA.